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Trial · NCT00086190

Registered outcomes17

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryChange in Hamilton Depression Rating Scale (HAM-D) Scoresfrom the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Change in Hamilton Rating Scale for Depression over 12 weeks. Hamilton Depression Rating Scale ranges from 0-50. Higher scores represent more significant depression. Mild depression ranges from 8-13, moderate depression from 14-18, severe 19-22 and very severe any score over 23.
SecondaryChange in Montgomery-Asberg Depression Rating Scale (MADRS)from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Montgomery-Asberg Depression Rating Scale ranges from 0-60. Higher score indicates more severe depression. 0-6 normal, 7-19 mild depression, 20-34 moderate depression, greater than 34 severe depression.
SecondaryChange in Beck Depression Inventory II (BDI-II)from the beginning (0 weeks) to end (12 weeks) of the double-blind phaseBeck Depression Inventory II ranges from 0-63. Higher score indicates more severe depression. 0-13 minimal depression, 14-19 mild depression, 20-28 moderate depression, 29-63 severe depression.
SecondaryChange in Geriatric Depression Rating Scale (GDS)from the beginning (0 weeks) to end (12 weeks) of the double-blind phaseGeriatric Depression Scale ranges from 0-30. Higher score indicates more severe depression. 0-9 normal, 10-19 mild depression, 20-30 severe depression.
SecondaryChange in Brief Psychiatric Rating Scale (BPRS)from the beginning (0 weeks) to end (12 weeks) of the double-blind phaseBrief Psychiatric Rating Scale. Maximum score 126. Higher score indicates greater psychiatric difficulties.
SecondaryChange in Unified Parkinson's Disease Rating Scale (UPDRS)from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Unified Parkinson's Disease Rating Scale. Higher score indicates more severe Parkinson's disease symptoms. Total maximum = 176. Mental maximum = 52, Activities of Daily Living maximum = 52, Motor maximum = 72. Minimum = 0.
SecondaryChange in Snaith Clinical Anxiety Scale (CAS)from the beginning (0 weeks) to end (12 weeks) of the double-blind phaseSnaith Clinical Anxiety Scale. Range 0-21. Higher scores indicate increased anxiety. Score greater than 8 indicates clinical anxiety.
SecondaryChange in Pittsburgh Sleep Quality Index (PSQI)from the beginning (0 weeks) to end (12 weeks) of the double-blind phasePittsburgh Sleep Quality Index scores range from 0-21, with higher scores indicating severe sleep difficulties.
SecondaryChange in Unified Parkinson's Disease Rating Scale (UPDRS) - Motorfrom the beginning (0 weeks) to end (12 weeks) of the double-blind phaseUnified Parkinson's Disease Rating Scale - Motor has a maximum score of 72, minimum score of 0. Higher score indicates more severe Parkinson's disease symptoms.
SecondaryChange in Unified Parkinson's Disease Rating Scale (UPDRS) - Tremorfrom the beginning (0 weeks) to end (12 weeks) of the double-blind phaseUnified Parkinson's Disease Rating Scale - Tremor subscale ranges from 0-23. Higher score indicates more severe Parkinson's disease symptoms.
SecondaryChange in Unified Parkinson's Disease Rating Scale (UPDRS) - Bulbarfrom the beginning (0 weeks) to end (12 weeks) of the double-blind phaseUnified Parkinson's Disease Rating Scale - Bulbar maximum score 24, minimum score of 0. Higher score indicates more severe Parkinson's disease symptoms.
SecondaryChange in Parkinson's Disease Questionnaire (PDQ) - 39 - Overallfrom the beginning (0 weeks) to end (12 weeks) of the double-blind phaseParkinson's Disease Questionnaire (PDQ-39) Total. Range 0-100. Lower score indicates a better perceived health status.
SecondaryChange in Parkinson's Disease Questionnaire (PDQ) - 39 - Emotional Well-Beingfrom the beginning (0 weeks) to end (12 weeks) of the double-blind phaseParkinson's Disease Questionnaire (PDQ-39) - Emotional Well-Being maximum score 24, minimum score of 0.Lower score indicates a better perceived health status.
SecondaryChange in Short Form 36 Health Survey - Mental Component Summaryfrom the beginning (0 weeks) to end (12 weeks) of the double-blind phaseShort Form 36 Health Survey. Range 0-100. Higher score indicates a better perceived quality of life.
SecondaryChange in Short Form 36 Health Survey - Vitalityfrom the beginning (0 weeks) to end (12 weeks) of the double-blind phaseShort Form 36 Health Survey - Vitality subscale ranges from 0-100. Higher score indicates a better perceived quality of life.
SecondaryChange in Short Form 36 Health Survey - Role-Emotionalfrom the beginning (0 weeks) to end (12 weeks) of the double-blind phaseShort Form 36 Health Survey - Emotional subscale ranges from 0-100. Higher score indicates a better perceived quality of life.
SecondaryChange in Short Form 36 Health Survey - Mental Healthfrom the beginning (0 weeks) to end (12 weeks) of the double-blind phaseShort Form 36 Health Survey - Mental Health subscale ranges from 0-100. Higher score indicates a better perceived quality of life.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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